البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
ALGLUCOSIDASE ALFA
SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC
A16AB07
ALGLUCOSIDASE ALFA
50MG
POWDER FOR SOLUTION
ALGLUCOSIDASE ALFA 50MG
INTRAVENOUS
10.3ML
Prescription
ENZYMES
Active ingredient group (AIG) number: 0151663001; AHFS:
APPROVED
2006-08-14
_Product Monograph Master Template _ _Template Date: September 2020 _ _MYOZYME (alglucosidase alfa) _ _Page 1 of 43_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MYOZYME ® alglucosidase alfa (Recombinant human acid alpha-glucosidase) Lyophilized Powder, 50 mg vial, intravenous infusion ATC code: A16AB07 Enzyme Replacement Therapy Produced by recombinant DNA technology in Chinese hamster ovary cell line Sanofi Genzyme, a division of sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval, Quebec H7V 0A3 Date of Initial Authorization: December 6, 2006 Date of Revision: November 24, 2023 Submission Control No: 270219 _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _اقرأ الوثيقة كاملة _ _Page 2 of 43_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, 7.1.1 PREGNANT WOMEN 11/2022 7 WARNINGS AND PRECAUTIONS, 7.1.2 BREAST-FEEDING 11/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ............................................................................................................... 4 Pediatrics .......................................................................................................................... 4 Geriatrics .......................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION .............